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Effect of Nutritional Supplementation on Pediatric Burn Patients

Primary Purpose

Burns

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Nutritional Supplement
Hospital food
Sponsored by
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 1-10 years of age
  2. Hospital admission within 24 hours post-burn
  3. At least 15% TBSA burned to at least 2nd degree and no more than 5% TBSA 4th degree or higher
  4. Capable of exclusive oral feeding within 3 days of hospitalization
  5. Expected to be hospitalized at least 14 days

Exclusion Criteria:

  1. History diabetes or stress-induced hyperglycemia
  2. Artificial ventilation
  3. Requires parenteral or enteral feeding
  4. IV albumin
  5. Drug that affects metabolism
  6. Receiving Dialysis
  7. Acutely impacted or constipated
  8. Consumes non-study nutritional supplement
  9. Allergy or intolerance to any study product ingredient
  10. Participating in non-Abbott approved concomitant trial

Sites / Locations

  • Children City Clinical Hospital #9
  • First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic
  • Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic
  • City Clinical Hospital #2
  • Children's City Hospital #9
  • Nizhny Novgorod Research Institute of Traumatology & Orthopedics of Federal Agency of High Technology Medical Care
  • City Hospital #20
  • City Clinical Hospital #7
  • Children's City Hospital #1

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hospital Feed

Hospital Feed plus nutritional supplement

Arm Description

Standard hospital food

Standard hospital food plus nutritional supplement

Outcomes

Primary Outcome Measures

prealbumin

Secondary Outcome Measures

Preablumin
C Reactive Protein (CRP)
C Reactive Protein

Full Information

First Posted
November 1, 2011
Last Updated
September 4, 2012
Sponsor
Abbott Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT01464866
Brief Title
Effect of Nutritional Supplementation on Pediatric Burn Patients
Official Title
Effect of Nutritional Supplementation on Pediatric Burn Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hospital Feed
Arm Type
Active Comparator
Arm Description
Standard hospital food
Arm Title
Hospital Feed plus nutritional supplement
Arm Type
Experimental
Arm Description
Standard hospital food plus nutritional supplement
Intervention Type
Other
Intervention Name(s)
Nutritional Supplement
Intervention Description
Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.
Intervention Type
Other
Intervention Name(s)
Hospital food
Intervention Description
Typical hospital food given daily at meals
Primary Outcome Measure Information:
Title
prealbumin
Time Frame
Change between Baseline and Day 14
Secondary Outcome Measure Information:
Title
Preablumin
Time Frame
Change between Baseline and Day 7
Title
C Reactive Protein (CRP)
Time Frame
Between baseline and Day 7
Title
C Reactive Protein
Time Frame
Between baseline and Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1-10 years of age Hospital admission within 24 hours post-burn At least 15% TBSA burned to at least 2nd degree and no more than 5% TBSA 4th degree or higher Capable of exclusive oral feeding within 3 days of hospitalization Expected to be hospitalized at least 14 days Exclusion Criteria: History diabetes or stress-induced hyperglycemia Artificial ventilation Requires parenteral or enteral feeding IV albumin Drug that affects metabolism Receiving Dialysis Acutely impacted or constipated Consumes non-study nutritional supplement Allergy or intolerance to any study product ingredient Participating in non-Abbott approved concomitant trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Williams, MPH
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
Children City Clinical Hospital #9
City
Ekaterinburg
ZIP/Postal Code
620134
Country
Russian Federation
Facility Name
First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic
City
Izhevsk
ZIP/Postal Code
426039
Country
Russian Federation
Facility Name
Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic
City
Kazan
ZIP/Postal Code
420138
Country
Russian Federation
Facility Name
City Clinical Hospital #2
City
Kemerovo
ZIP/Postal Code
650033
Country
Russian Federation
Facility Name
Children's City Hospital #9
City
Moscow
ZIP/Postal Code
123317
Country
Russian Federation
Facility Name
Nizhny Novgorod Research Institute of Traumatology & Orthopedics of Federal Agency of High Technology Medical Care
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
City Hospital #20
City
Rostov-na-Donu
ZIP/Postal Code
344091
Country
Russian Federation
Facility Name
City Clinical Hospital #7
City
Saratov
ZIP/Postal Code
410005
Country
Russian Federation
Facility Name
Children's City Hospital #1
City
St. Petersburg
ZIP/Postal Code
198205
Country
Russian Federation

12. IPD Sharing Statement

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Effect of Nutritional Supplementation on Pediatric Burn Patients

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